Treatment of Graves' Hyperthyroidism With Selenium Plus Methimazole

Sponsor

University of Pisa (Other)

Overall Status

Completed

CT.gov ID

NCT02727738

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluation of the efficacy of the combined treatment (methimazole plus selenium) in the control of hyperthyroidism as compared to methimazole alone in 30 Graves' disease (GD) untreated patients.

Condition or Disease	Intervention/Treatment	Phase
Graves' Disease	Dietary Supplement: Selenium Drug: Methimazole	N/A

Detailed Description

30 untreated GD hyperthyroid patients will be randomized into two groups (A and B). Group A patients will be treated with an anti-thyroid drug (methimazole) at the dose aimed to control hyperthyroidism. Group B patients will be treated with methimazole plus selenium (160 mg daily). Patients will be evaluated at time 0, 45 and 90 days for symptoms of hyperthyroidism (by a specific questionnaire), clinical status (weight, heart rate), laboratory (thyroid function tests, TSHR autoantibodies, serum selenium, index of oxidative stress-MDA, cholesterol, SHBG) and EKG. The aim of the study is to evaluate if the combined treatment (methimazole plus selenium) is more effective than methimazole alone in controlling GD hyperthyroidism.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomized Open Clinical Study to Evaluate the Efficacy of Selenium Plus Methimazole for Treatment of Graves' Hyperthyroidism

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Methimazole plus selenium Methimazole 5-30 mg daily for 90 days Selenium 80 bid for 90 days	Dietary Supplement: Selenium Selenium 80 mg bid for 90 days Other Names: Syrel Drug: Methimazole Methimazole starting dose depending on FT3 values (15 mg/day or 20 mg/day or 30 mg/day, for FT3 values <10 pg/ml, 10-15 pg/ml, >15 pg/ml, respectively) to be tapered by 5 mg/day every 15 days down to values sufficient for FT3 to be normal Other Names: Tapazole
Active Comparator: Methimazole Methimazole 5-30 mg daily for 90 days	Drug: Methimazole Methimazole starting dose depending on FT3 values (15 mg/day or 20 mg/day or 30 mg/day, for FT3 values <10 pg/ml, 10-15 pg/ml, >15 pg/ml, respectively) to be tapered by 5 mg/day every 15 days down to values sufficient for FT3 to be normal Other Names: Tapazole

Arm

Intervention/Treatment

Experimental: Methimazole plus selenium

Methimazole 5-30 mg daily for 90 days Selenium 80 bid for 90 days

Dietary Supplement: Selenium

Selenium 80 mg bid for 90 days

Other Names:

Syrel

Drug: Methimazole

Methimazole starting dose depending on FT3 values (15 mg/day or 20 mg/day or 30 mg/day, for FT3 values <10 pg/ml, 10-15 pg/ml, >15 pg/ml, respectively) to be tapered by 5 mg/day every 15 days down to values sufficient for FT3 to be normal

Other Names:

Tapazole

Active Comparator: Methimazole

Methimazole 5-30 mg daily for 90 days

Drug: Methimazole

Other Names:

Tapazole

Outcome Measures

Primary Outcome Measures

Control of hyperthyroidism [90 days]
Comparison of FT3 and FT4 values (pg/ml) between groups
Clinical manifestations of hyperthyroidism-1 [90 days]
Comparison of heart rate between groups
Clinical manifestations of hyperthyroidism-2 [90 days]
Comparison of BMI between groups
Clinical manifestations of hyperthyroidism-3 [90 days]
Comparison of total serum cholesterol between groups
Clinical manifestations of hyperthyroidism-4 [90 days]
Comparison of total serum sex hormone binding globulin between groups
Clinical manifestations of hyperthyroidism-5 [90 days]
Comparison of subjective hyperthyroidism symptoms score collected by questionnaire between groups

Secondary Outcome Measures

Control of hyperthyroidism [45 days]
Comparison of FT3 and FT4 values (pg/ml) between groups
Clinical manifestations of hyperthyroidism-1 [45 days]
Comparison of heart rate between groups
Selenium levels [45 days]
Comparison of serum selenium levels between groups
Selenium levels [90 days]
Comparison of serum selenium levels between groups
Oxidative stress parameters-1 [45 days]
Comparison of serum malondialdehyde levels between groups
Oxidative stress parameters-2 [45 days]
Comparison of serum glutathione peroxidase levels between groups
Thyroid autoimmunity-1 [45 days]
Comparison of serum anti-thyroperoxidase antibodies levels and prevalence between groups
Thyroid autoimmunity-2 [45 days]
Comparison of serum anti-thyrotropin receptor antibodies levels and prevalence between groups
Oxidative stress parameters-1 [90 days]
Comparison of serum malondialdehyde levels between groups
Oxidative stress parameters-2 [90 days]
Comparison of serum glutathione peroxidase levels between groups
Thyroid autoimmunity-1 [90 days]
Comparison of serum anti-thyroperoxidase antibodies levels and prevalence between groups
Thyroid autoimmunity [90 days]
Comparison of serum anti-thyrotropin receptor antibodies levels and prevalence between groups
Adverse events of selenium [45 days]
Adverse events of selenium [90 days]
Clinical manifestatations of hyperthyroidism-2 [45 days]
Comparison of BMI between groups
Clinical manifestations of hyperthyroidism-3 [45 days]
Comparison of total serum sex hormone binding globulin between groups
Clinical manifestations of hyperthyroidism-4 [45 days]
Comparison of subjective hyperthyroidism symptoms score collected by questionnaire between groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Hyperthyroid untreated Graves' disease patients

Exclusion Criteria:

Hyperthyroid treated Graves' disease patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Endocrinology Unit	Pisa	PI	Italy	56124

Sponsors and Collaborators

University of Pisa

Investigators

Principal Investigator: Claudio Marcocci, MD, Department of Clinical and Experimental Medicine, University of Pisa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marinò Michele, MD, University of Pisa

ClinicalTrials.gov Identifier:

NCT02727738

Other Study ID Numbers:

UPisa

First Posted:

Apr 5, 2016

Last Update Posted:

Apr 6, 2016

Last Verified:

Apr 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Marinò Michele, MD, University of Pisa

Hyperthyroidism

Methimazole

Selenium

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2016